Edoxaban Treatment in Routine Clinical Practice for Patients With Non-valvular Atrial Fibrillation (ETNA-AF-Hong Kong)
August 17, 2022 updated by: Daiichi Sankyo Hong Kong Ltd., a Daiichi Sankyo Company
Non-interventional Study on Edoxaban Treatment in Routine Clinical Practice for Patients With Non-valvular Atrial Fibrillation (ETNA-AF-Hong Kong)
In order to understand the risks and benefits of edoxaban use in a real-world clinical setting in the NVAF indication, Daiichi-Sankyo Hong Kong proposed this non-interventional study (NIS) to gain insight into the safety of edoxaban use in non-preselected patients with NVAF.
Study Overview
Detailed Description
Edoxaban was approved by the Pharmacy and Poisons Board in Hong Kong (date: 31 May 2016) for the: Prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation (NVAF) with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischemic attack (TIA). Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.
In order to understand the risks and benefits of edoxaban use in a real-world clinical setting in the NVAF indication, Daiichi-Sankyo proposed this non-interventional study (NIS) to gain insight into the safety of edoxaban use in non-preselected patients with NVAF.
Real world evidence from routine clinical practice using edoxaban up to 2 years will be collected and evaluated in approximately 200 patients, treated by specialized as well as non-specialized physicians in hospital centers.
Study Type
Observational
Enrollment (Actual)
234
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Hong Kong, Hong Kong
- Prince of Wales Hospital (1082)
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Hong Kong, Hong Kong
- Prince of Wales Hospital (1083)
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Hong Kong, Hong Kong
- Queen Mary Hospital, Department of Cardiology (1801)
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Hong Kong, Hong Kong
- Queen Mary Hospital, Department of Neurology (1805)
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Primary strategy is to include only patients with NVAF who are to be treated with edoxaban according to Package Information (Summary of Product Characteristics (SmPC)).
To ensure that the physician's prescribing behaviour will not be influenced, patients may only be included after the treating physician has made the clinical decision to prescribe edoxaban.
Patients must have provided written informed consent for participation in the study (ICF) and should not participate simultaneously in any interventional study.
Description
Inclusion Criteria:
- Is a NVAF-patient whose physician has made the clinical decision to prescribe edoxaban therapy according to Package Information
- Has provided written informed consent to participate in the study
Exclusion Criteria:
- Is participating in an interventional study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Edoxaban
NVAF Patients treated with Edoxaban
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Edoxaban according to Package Information (Summary of Product Characteristics (SmPC)).
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of participants with real world safety events
Time Frame: 2 years
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of participants with patient relevant outcomes
Time Frame: 2 years
|
Categories: Strokes (ischaemic and haemorrhagic), Systemic Embolic Events (SEE), Transient Ischemic Attack (TIA), Major Adverse Cardiovascular Events (MACE), Venous Thromboembolism (VTE), Acute Coronary Syndrome (ACS), Hospitalisations related to cardiovascular (CV) condition
|
2 years
|
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Average duration of exposure to edoxaban
Time Frame: within 2 years
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within 2 years
|
|
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Number of participants compliant with edoxaban therapy
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Late Phase Operations Lead, Global Medical Affairs, Daiichi Sankyo, Inc.
- Study Chair: Study Project Manager, Daiichi Sankyo (Hong Kong), Ltd.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 2, 2017
Primary Completion (Actual)
May 3, 2022
Study Completion (Actual)
May 3, 2022
Study Registration Dates
First Submitted
August 9, 2017
First Submitted That Met QC Criteria
August 9, 2017
First Posted (Actual)
August 11, 2017
Study Record Updates
Last Update Posted (Actual)
August 18, 2022
Last Update Submitted That Met QC Criteria
August 17, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DU176b-C-A4012
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/.
In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants.
Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
IPD Sharing Time Frame
Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
IPD Sharing Access Criteria
Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research.
This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Clinical Study Report (CSR)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.